Events

Rappel de Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary phase issue)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00370-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-03-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00370-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    An issue has been identified where a retrospective respiratory gated 4d ct scan is performed with the bellows pulmonary gating device, the ct images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%). this may lead to a couple of scenarios that may result in misrepresentation of the 4d ct images with a respiratory gated 4d ct scan and reconstruction. in the event this occurs a misrepresentation of ct images may result, due to the incorrect image pulmonary phase annotation or the need to rescan the patient due to an incorrect image pulmonary phase.
  • Action
    Philips is recommending users to follow the instructions as outlined in the recall notification letter. The letter contains information to prevent the occurrence of the scenarios as well as the corrective actions to take when they do occur.

Device

Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary ph...
  • Modèle / numéro de série
    Brilliance Big Bore Oncology CT and Radiology CT (with software version 4.2.0)(4D CT pulmonary phase issue)ARTG Number: 98868
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA